A phase II trial of vinflunine chemotherapy in locally advanced and metastatic carcinoma of the penis.
Disease site: Urological cancers
Treatment modality: Systemic therapy (chemotherapy)
VinCaP is a non-randomised, multicentre, phase II trial to determine the clinical benefit and toxicity of vinflunine chemotherapy in patients with inoperable (locally advanced or metastatic) cancer of the penis. The trial will determine whether this drug warrants further research in this patient group.
Twenty-two evaluable patients will be recruited from UK sites over a two-year period to receive vinflunine (320 mg/m2) every 21 days. Four cycles will be administered prior to formal restaging of disease. Patients with clinical benefit will continue on treatment until disease progression or until toxicity supervenes, or until treatment is discontinued according to clinician or patient decision. Patients will be followed up for a maximum of 24 months.
Chief Investigator: Dr Lisa Pickering, St George’s Healthcare NHS Trust
Clinical Co-ordinator: Dr Steve Nicholson, Consultant in Medical Oncology, & International Study Chair, International Rare Cancers Initiative in Penile Cancer
ICR-CTSU Statistical Lead: Dr Emma Hall
Trial management contact: [email protected]
Sponsor: The Institute of Cancer Research
View VinCaP on the National Institute for Health Research website: NIHR - Be Part Of Research
Patient friendly information is available from Cancer Research UK
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